Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome

This study is currently recruiting participants.
Verified March 2014 by University of Washington
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01807091
First received: March 6, 2013
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

This pilot clinical trial studies the feasibility of having induction chemotherapy in an outpatient setting. Patients with acute leukemia (AML) or advanced myelodysplastic syndrome (MDS), at least 18 years of age will be examined. Treating eligible patients with induction chemotherapy in an outpatient setting may save in healthcare cost and improve a patients' quality of life.


Condition Intervention
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Acute Myelomonocytic Leukemia (M4)
Adult Erythroleukemia (M6a)
Adult Pure Erythroid Leukemia (M6b)
de Novo Myelodysplastic Syndromes
Previously Treated Myelodysplastic Syndromes
Recurrent Adult Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia
Drug: chemotherapy

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility of Outpatient Induction Chemotherapy for Adult Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Rate of hospital admission [ Time Frame: During the 4-7 days of outpatient chemotherapy ] [ Designated as safety issue: No ]
  • Patient death [ Time Frame: During the 14 days after beginning outpatient treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: May 2013
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (chemotherapy)
Patients receive outpatient induction chemotherapy.
Drug: chemotherapy
Receive outpatient induction chemotherapy
Other Name: chemo

Detailed Description:

PRIMARY OBJECTIVES:

I. Assess the feasibility of outpatient induction therapy for acute myeloid leukemia (AML) or advanced myelodysplastic syndrome (MDS) by examining whether > 50% of patients treated as outpatients can complete chemotherapy without being admitted to hospital or < 5% of patients die within 14 days of beginning outpatient chemotherapy.

OUTLINE:

Patients receive outpatient induction chemotherapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed written informed consent

    • The signed informed consent
    • The benefits / risks of the induction chemotherapy regimen will be reviewed, and a second consent may be necessary if the regimen will be administered according to a separate protocol
  • AML (acute promyelocytic leukemia [APL] excepted) or high-risk MDS (10-19% blasts in marrow by morphology or flow cytometry or blood)
  • Treatment-related mortality (TRM) score < 9.21 corresponding to a TRM rate of 3% when chemotherapy of similar intensity as proposed here is administered to inpatients
  • White blood cell (WBC) count =< 10,000
  • Fibrinogen > 200
  • Afebrile with a clear chest x-ray and no signs of active viral, bacterial, or fungal infection
  • Adequate cardiac function as demonstrated by left ventricular ejection fraction (LVEF) of 45% or greater by multiple gated acquisition (MUGA) or echocardiogram
  • No ongoing cardiac issues such as uncontrolled arrhythmias or unstable angina or congestive heart failure
  • Patient must have an outpatient caregiver available
  • Patient must live within 30 minutes of the Seattle Cancer Care Alliance during outpatient treatment
  • Patient must be willing to return to the Seattle Cancer Care Alliance for outpatient follow-up once outpatient treatment is completed
  • Logistical requirements:

    • Space available in infusion room
    • Outpatient infusion pump available if continuous infusion required
    • Case discussed with infusion room nursing staff
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01807091

Locations
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Pamela S. Becker    206-616-1589      
Principal Investigator: Pamela S. Becker         
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Pamela Becker Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01807091     History of Changes
Other Study ID Numbers: 7910, NCI-2013-00483, 7910, P30CA015704
Study First Received: March 6, 2013
Last Updated: March 19, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Congenital Abnormalities
Leukemia
Leukemia, Erythroblastic, Acute
Leukemia, Megakaryoblastic, Acute
Leukemia, Monocytic, Acute
Leukemia, Myeloid
Leukemia, Myelomonocytic, Acute
Myelodysplastic Syndromes
Preleukemia
Leukemia, Myelomonocytic, Chronic
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Myelodysplastic-Myeloproliferative Diseases

ClinicalTrials.gov processed this record on April 17, 2014